KN-550, KN-550N ,KN-520 and KD-5005 Fully Automatic Electronic Blood Pressure Monitor. is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.

Device Description

KN-550, KN-550N ,KN-520 and KD-5005Fully Automatic Electronic Blood Monitor. is designed and manufactured Pressure according to IEC80601-2-30--manual, electronic or automated sphygmanometers.

The operational principle is based on oscillometric and silicon integrates pressure sensor technology. it can calculate the systolic and diastolic blood pressure, the measurements results can also be classified by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown to the user. More over, it also obtains the function of averaging the measurement results. Achieves its function by an LCD or other display components.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the KN-550, KN-550N, KN-520, and KD-5005 Fully Automatic Electronic Blood Pressure Monitors:

1. A table of acceptance criteria and the reported device performance

The provided text does not explicitly state specific numerical acceptance criteria for accuracy or performance figures from a clinical study. Instead, it relies on conformity to international standards, particularly IEC 80601-2-30.

The document states:

"Safety and performance characteristics of the test according to IEC 80601-2-30"
"Fully Automatic Electronic Blood Pressure Monitor conforms to the following standards: ... IEC 80601-2-30:2009+Cor.2010/EN 80601-2-30:2010 (Medical electrical equipment -Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers)"

Therefore, the acceptance criteria are implicitly defined by the requirements of IEC 80601-2-30, which specifies accuracy limits for automated sphygmomanometers. Without access to the full standard document, specific numerical criteria for bias and standard deviation cannot be extracted directly from this 510(k) summary.

Reported Device Performance:
The document does not report specific accuracy performance metrics like mean difference (bias) and standard deviation found in clinical validation studies. It only states that the device "conforms to" and "meets standards," implying that its performance is within the acceptable limits of IEC 80601-2-30.

Acceptance Criteria (Implied by Standard)	Reported Device Performance
Accuracy defined by IEC 80601-2-30	Conforms to IEC 80601-2-30
(Specific numerical limits for bias and standard deviation not provided in this summary)	(Specific numerical performance metrics not provided in this summary)
Electrical Safety	Conforms to IEC 60601-1 and IEC 60601-1-1
Electromagnetic Compatibility (EMC)	Conforms to IEC 60601-1-2

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Non-clinical Tests have been done as follows:" but then proceeds to list conformity to standards rather than detailing a specific clinical test with a sample size. It does not provide information on:

Sample size for any test set (clinical or otherwise).
Data provenance (e.g., country of origin).
Whether any specific clinical data used for validation was retrospective or prospective.

The phrase "Safety and performance characteristics of the test according to IEC 80601-2-30" suggests that validation was performed following the standard's methodology, which typically involves clinical testing on a specified number of subjects. However, the details of that specific test (like sample size) are not provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. For blood pressure monitors, ground truth is typically established by trained medical personnel using auscultation with a mercury sphygmomanometer, often with multiple observers for inter-observer variability, as per accepted validation protocols (e.g., ISO, BHS, AAMI). However, the details of such ground truth establishment for this specific device's validation are absent from this summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable to this device. The device is a "Fully Automatic Electronic Blood Pressure Monitor," which measures blood pressure automatically and does not involve human readers interpreting images or data where AI assistance would be relevant in an MRMC study context. There is no AI component mentioned for human assistance in this device description, nor any indication of an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is marketed as a "Fully Automatic Electronic Blood Pressure Monitor," which inherently operates in a standalone manner without continuous human intervention during the measurement process. The conformity to IEC 80601-2-30 implies that its standalone performance (accuracy, safety) was assessed. However, the summary does not detail a specific "standalone study" in the context of an algorithm's performance as might be done for diagnostic AI. Here, "standalone" simply means the device performs its function by itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document does not explicitly state the type of ground truth used. For blood pressure monitors validated according to standards like IEC 80601-2-30, the ground truth for blood pressure measurements is typically established through simultaneous or sequential measurements by trained observers using a reference method (e.g., auscultation with a mercury sphygmomanometer or another validated device). This involves a comparative measurement against a highly accurate, often manually performed, technique.

8. The sample size for the training set

This information is not provided and is largely irrelevant for this type of device. Electronic blood pressure monitors are typically based on oscillometric principles, which are well-established algorithms that don't involve "training sets" in the machine learning sense for individual device models. The algorithms are usually developed and refined over time based on engineering principles and general physiological data, not specific training sets for a given 510(k) submission.

9. How the ground truth for the training set was established

This information is not provided and, as noted above, a "training set" in the context of machine learning is not applicable here. The underlying algorithms for oscillometric measurement are established physiological and engineering principles.

Summary

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K140121

KN-550, KN-550N ,KN-520 and KD-5005 Fully Automatic Electronic Blood Pressure Monitor FDA 510(k) Files

510(k) Summary

JUL 0 2 2014

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA and 21 CFR 807.92.

1.0 submitter's information

Name:	Andon Health Co., Ltd.
Address:	No 3, Jinping Street Ya An Road, Nankai District, Tianjin,P.R. China
Phone number:	86-22-6052 6161
Fax number:	86-22-6052 6162
Contact:	Liu Yi
Date of Application:	12/27/2013

2.0 Device information

Trade name:	KN-550, KN-550N, KN-520 and KD-5005 Fully AutomaticElectronic Blood Pressure Monitor.
Device name:	KN-550,KN-550N,KN-520 and KD-5005Fully AutomaticElectronic Blood Pressure Monitor.
Classification name:	Noninvasive blood pressure measurement system

3.0 Classification

រូ

Production code: DXN- Noninvasive blood pressure measurement system. Regulation number: 870.1130 Classification: II Panel: Cardiovascular

4.0 Predicate device information

Manufacturer:	Andon Health Co., Ltd.
Device:	KD-513LU Fully Automatic Electronic Blood PressureMonitor.
510(k) number:	K121372

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K140121

5.0 Intended use

KN-550, KN-520 and KD-5005 Fully Automatic Electronic Blood Pressure Monitor. are for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.

The intended use and the indication for use of KN-550, KN-550N ,KN-520 and KD-5005Fully Automatic Electronic Blood Pressure Monitor., as described in its labeling are the same as the predicate device KD-513LU .

6.0 Device description

KN-550, KN-550N ,KN-520 and KD-5005Fully Automatic Electronic Blood Monitor. is designed and manufactured Pressure according to IEC80601-2-30--manual, electronic or automated sphygmanometers.

Technological Characteristics	Comparison result
Design principle	Identical
Appearance	Similar
Patients contact Materials	Identical
Performance	Similar
Biocompatibility	Identical
Mechanical safety	Identical
Energy source	Identical
Standards met	Identical
Electrical safety	Identical
EMC	Identical
Function	Similar

7.0 Summary comparing technological characteristics with predicate device

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K140121

KN-550, KN-550N ,KN-520 and KD-5005 Fully Automatic Electronic Blood Pressure Monitor FDA 510(k) Files

8.0 Discussion of non-clinical and clinical test performed

Non-clinical Tests have been done as follows:

a. Electromagnetic compatibility test according to IEC 60601-1-2;

b. Electrical safety according test to IEC 60601-1 and IEC 60601-1-1

c. Safety and performance characteristics of the test according to IEC 80601-2-30 ·

None of the test demonstrates that KN-550, KN-550N-,KN-520 and KD-5005 Blood Pressure Monitor brings new questions of safety and Fully Automatic effectiveness.

9.0 Performance summary

Fully Automatic Electronic Blood Pressure Monitor conforms to the following standards:

60601-1:2005/EN 60601-1:2006/AC:2010 (Medical electrical ● IEC equipment -- Part 1: General requirements for basic safety and essential performance)
IEC60601-1-2:2007/EN 60601-1-2:2007 /AC:2010 (Medical electrical
equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests)
· IEC 80601-2-30:2009+Cor.2010/EN 80601-2-30:2010(Medical electrical equipment -Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers)

10.0 Comparison to the predicate device and the conclusion

Our device KN-550, KN-520 and KD-5005Fully Automatic Electronic Blood Pressure Monitor. is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-513LU whose 510(k) number is K121372.

The five devices are very similar in the intended use, the design principle, the material, the performance and the applicable standards. Only their appearance, the memory time, and the user interface are different.

However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

July 2, 2014

Mr. Liu Yi, President Andon Health Co., Ltd. No 3, Jinping Street, Ya An Road, Nankai District Tianjin People's Republic of China 300190

K140121 Re:

Trade/Device Names: KN-550, KN-550N, KN-520 and KD-5005 Fully Automatic Electronic Blood Pressure Monitor Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: June 6, 2014 Received: June 9, 2014

Dear Mr. Liu:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Liu Yi

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and fisting (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

forBram D. Zuckerman, M.D. Director

Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Indications for Use

510(k) Number :	K140121
Device name:	KN-550, KN-550N ,KN-520 and KD-5005 Fully Automatic Electronic Blood Pressure Monitor.

Indications for use:

Prescription use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use YES (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-COUNTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Date
2014.07.02
17:27:52 -04'00'

Page 1 of 1

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).